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510(k) Data Aggregation

    K Number
    K140807
    Device Name
    COMPOSITE ORTHODONTIC BRACKETS
    Manufacturer
    ORTHO SPECIALTIES
    Date Cleared
    2014-11-12

    (225 days)

    Product Code
    DYW
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORTHO SPECIALTIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Composite Brackets are intended for use as a clear, plastic bracket system to provide orthodontic movement of natural teeth.
    Device Description
    Composite brackets provide a clear, aesthetic option for patients undergoing orthodontic treatment. The Composite Bracket system is designed to provide simple, aesthetic bonded brackets to correct minor to complicated mal-alignments in patients with permanent dentition (second molars) or mixed dentition using current orthodontic diagnosing techniques with orthodontic arch wires. The system consists of a series of clear, plastic brackets that conform to each tooth and its anatomy and adheres with a bracket base bearing a mechanical retention surface. They are provided with or without a metal archwire slot. Additional accessories to the brackets, depending on the dental professionals' technique, mav include small hooks for the use of elastics and auxiliary arch wire tubes. Each bracket applies incremental, progressive force to reposition teeth to achieve ideal alignment, as prescribed by the treating dental practitioner. The composite brackets are bonded to the patient's teeth by traditional orthodontic direct and indirect bonding techniques using Orthodontic adhesives.
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